Proton Therapy With Chemotherapy for Stage III Non-Small Cell Lung Cancer (LU02) (LU02)

August 10, 2017 updated by: University of Florida

A Phase II Trial of 3 Dimensional Proton Radiotherapy With Concomitant Chemotherapy for Patients With Initially Unresectable Stage III Non-Small Cell Lung Cancer

The purpose of this study is to find out what effects, good and/or bad, proton radiation at a higher tumor dose (and lower normal surrounding lung dose) combined with standard chemotherapy has on lung cancer. The dose you receive to the tumor will be higher than the standard dose. This may be able to increase the control of the tumor. Due to the accuracy of radiation given with protons, the dose to the normal lung tissue that surrounds the tumor will be lower than standard. This may be able to reduce the frequency and severity of the usual radiation side effects.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32206
        • University of Florida Proton Therapy Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically documented non-small cell carcinoma of the lung diagnosed within 16 weeks prior to study enrollment.
  • Patient must be at least 18 years old at the time of consent.
  • Stage III A or III B disease.
  • Patients must be able to start study treatment within 6 weeks of study enrollment.
  • Induction chemotherapy is allowed.
  • Marginally resectable or unresectable at presentation.
  • If the patient had exploratory thoracotomy, it must be done at least 3 weeks prior to enrollment.

Exclusion Criteria:

  • Evidence of distant metastasis.
  • Prior thoracic radiotherapy.
  • Any history of allergic reaction to taxanes.
  • Prior tumor resection. Candidate for upfront curative surgery.
  • Pleural effusion visible on chest x-ray or the scout view of the CT chest.
  • Unintentional weight loss within the month prior to diagnosis ≥ 10%.
  • Previous or concomitant malignancy other than early stage tumor treated more than 3 years ago for cure.
  • The presence of PET positive contralateral hilar disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET positive nodal disease measuring 15 mm or greater
Proton radiation with concomitant chemotherapy
Radiation: PET positive nodal disease measuring 15 mm or greater
Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy.
Other Names:
  • Proton Radiation
Experimental: PET positive nodal disease measuring less than 15 mm
Proton radiation
Radiation: PET positive nodal disease measuring less than 15 mm
Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy.
Other Names:
  • Proton Radiation
Experimental: Patients considered resectable
Proton radiation plus surgery
Radiation: Patients considered resectable
Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed.
Other Names:
  • Proton Radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities
Time Frame: Six months after end of radiation therapy
Six months after end of radiation therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Disease Control
Time Frame: Following treatment every 6 months for 2 years, then annually for 4 years.
Disease control rate is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). As per RECIST version 1.1, Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."), as accurate.
Following treatment every 6 months for 2 years, then annually for 4 years.
Percentage of Patients Alive at 5 Years
Time Frame: Five years following radiation treatment
Five years following radiation treatment
Feasibility, Safety and Efficacy of Delivering Proton Radiotherapy With Concomitant Chemotherapy
Time Frame: Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually
Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually
Correlation of Functional CT-PET Imaging With Treatment Outcomes
Time Frame: Prestudy, before surgery (if applicable) between days 18-22 if needed, then during follow-up every 6 months for 2 years, then annually for 4 years
Prestudy, before surgery (if applicable) between days 18-22 if needed, then during follow-up every 6 months for 2 years, then annually for 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Bradford S Hoppe, MD, MPH, University of Florida Proton Therapy Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

April 13, 2009

First Submitted That Met QC Criteria

April 13, 2009

First Posted (Estimate)

April 15, 2009

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFPTI 0802-LU02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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